VYLEESI (bremelanotide)

VYLEESI (bremelanotide)

SELF ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to:
  • A co-existing medical or psychiatric condition 
  • Problems with the relationship
  • The effects of a medication or drug substance
• Limitations of Use:
  • Vyleesi™ is not indicated for the treatment of HSDD in postmenopausal women or in men
  • Vyleesi™ is not indicated to enhance sexual performance

Patients must meet the following criteria for the indication(s) above:

• Patient is premenopausal, AND
• Patient’s symptoms of HSDD have persisted for a minimum of 6 months, AND
• The patient had normal sexual desire in the past, prior to the diagnosis of HSDD, AND
• Patient does not have a diagnosis of depression, AND
• If the patient is currently taking an antidepressant (for a diagnosis other than depression), the prescriber has determined that the antidepressant is not contributing to HSDD, AND
• Other known causes of HSDD (e.g. co-existing medical or psychiatric conditions, problems within a relationship, effects of medications, or drug abuse) have been ruled out, AND
• Chart notes document the average pre-treatment number of satisfying sexual events for the patient over a specific time frame, AND
• Patient does not have a contraindication to treatment (e.g. uncontrolled hypertension or known cardiovascular disease), AND
• Patient is not currently taking orally-administered naltrexone, AND
• Patient is not currently pregnant, AND
• Patient has tried and failed Addyi®

Reauthorization Criteria:

• The prescriber confirms significant increase in the number of satisfying sexual events from pre-treatment, AND
• Patient is premenopausal

Dosing:

• 1.75 mg administered subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity
• Do not administer more than 1 dose within 24 hours
• Do not administer more than 8 doses per month

Approval:

• Initial: 8 weeks
• Renewal: 6 months